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Bromocriptine in the Treatment of Peripartum Cardiomyopathy (BRO-HF)

This study is currently recruiting participants.
Verified September 2017 by Marc Jolicoeur, Montreal Heart Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02590601
First Posted: October 29, 2015
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Canadian Cardiovascular Society
Information provided by (Responsible Party):
Marc Jolicoeur, Montreal Heart Institute
  Purpose

Peripartum cardiomyopathy (PPCM) is a rare, but significant heart disease affecting young women in the puerperal period. Thus far, no specific treatment has been approved to treat this disease. PPCM has a wide spectrum of clinical manifestations ranging from mild heart failure to severe cardiomyopathy, cardiogenic shock and death. A significant proportion of survivors have persistent chronic heart failure leading to disabling symptoms and decreased quality of life.

Animal studies have suggested that prolactin is central to the development of PPCM. Prolactin has pro-inflammatory and anti-angiogenic effects that may promote PPCM. Bromocriptine, a central dopamine agonist known to decrease prolactin levels, might thwart its deleterious effects in women suffering from PPCM. Following this rationale, bromocriptine should improve myocardial function in women suffering from PPCM and thus, improve cardiovascular outcomes and healthcare outcomes.


Condition Intervention Phase
Peripartum Cardiomyopathy Drug: Bromocriptine Other: Guideline-driven medical therapy (GDMT) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bromocriptine in the Treatment of Peripartum Cardiomyopathy, A Bayesian Randomized Registry Trial

Resource links provided by NLM:


Further study details as provided by Marc Jolicoeur, Montreal Heart Institute:

Primary Outcome Measures:
  • MACE [ Time Frame: 1 year ]
    MACE : A compose of death from cardiovascular causes, aborted sudden death, heart transplantation, mechanical circulatory support or hospitalization for cardiovascular causes.


Secondary Outcome Measures:
  • Death from cardiovascular causes [ Time Frame: 5 years ]
  • Left ventricular ejection fraction (LVEF) recovery [ Time Frame: 6 months ]
    Recovery defined as : (proportion of patients with LVEF ≥ 54%)

  • All-cause mortality [ Time Frame: 5 years ]
  • Occurence of arrythmias [ Time Frame: 1 year ]
    Arrhythmia : Number of participants with sustained ventricular tachycardia, ventricular fibrillation or new onset atrial fibrillation

  • Number of all-cause hospitalisation [ Time Frame: 5 years ]
  • Health-related quality of life (HRQoL) with the Kansas City Cardiomyopathy questionnaire (KCCQ) [ Time Frame: 1 year ]
  • Health-related quality of life (HRQoL) with the World Health Organization (WHO) quality of life questionnaire (WHOQOL-BREF) [ Time Frame: 1 year ]
  • Heart transplantation [ Time Frame: 5 years ]
  • Mechanical circulatory support [ Time Frame: 1 year ]
  • Number of hospitalisation for cardiovascular causes [ Time Frame: 5 years ]

Other Outcome Measures:
  • Safety adverse events [ Time Frame: 12 months ]
    Safety adverse events: Combined occurence of venous thromboembolic disease, cardiac thrombus with embolic manifestation, myocardial infarction or cerebrovascular accident.


Estimated Enrollment: 80
Actual Study Start Date: January 1, 2017
Estimated Study Completion Date: January 1, 2023
Estimated Primary Completion Date: January 1, 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bromocriptine + Guideline-driven medical therapy

In addition to heart failure treatment described above, patients will be administered bromocriptine 2.5 mg orally twice daily for 14 days, followed by 2.5 mg orally daily for 42 days.

Although not a study procedure, we recommend anticoagulation with prophylactic doses of subcutaneous low-molecular weight heparin during the whole duration of bromocriptine therapy.

Drug: Bromocriptine Other: Guideline-driven medical therapy (GDMT)
Guideline-driven medical therapy
New onset PPCM will be managed according to the principles of guideline-driven medical therapy for new-onset heart failure as per the position statement for treatment of PPCM published by the European Society of Cardiology (ESC) and the Canadian Cardiovascular Society (CCS) update on heart failure and pregnancy . The choices and administration of GDMT will be left at the discretion of the treating physician
Other: Guideline-driven medical therapy (GDMT)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Peripartum cardiomyopathy defined by the following criteria:

    • Development of heart failure in the last month of pregnancy or within 5 months of delivery;
    • Absence of an identifiable alternative cause of heart failure;
    • Absence of recognizable heart disease prior to the last month of pregnancy;
    • Left ventricular systolic dysfunction demonstrated by classic echocardiographic criteria, such as depressed ejection fraction;
  3. Recent onset of PPCM ( 1 month);
  4. Written informed consent.

Exclusion Criteria:

  1. Hypersensitivity or contraindication to bromocriptine;
  2. Patients already taking bromocriptine for PPCM or for another indication;
  3. Cardiogenic shock before enrolment;
  4. Survival expected to be less than 1 year due to non-cardiovascular causes (eg. cancer);
  5. Participation to another investigational drug or investigational device study within 30 days prior to randomization (participation to registries is allowed);
  6. Patients who in the opinion of the investigator will not comply with specified drugs, or follow-up evaluation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590601


Contacts
Contact: Marc Jolicoeur, MD, M.Sc., MHS 514-376-3330 ext 3685 marc.jolicoeur@icm-mhi.org
Contact: Marie-Gabrielle Lessard, RN, B.Sc. Phone: 514-376-3330 ext 2094/2 marie-gabrielle.lessard@icm-mhi.org

Locations
Canada, Quebec
Montreal Heart Institute Recruiting
Monteal, Quebec, Canada, H1T 1C8
Contact: Marc Jolicoeur, MD, M.Sc., MHS    514-376-3330 ext 3685    marc.jolicoeur@icm-mhi.org   
Contact: Luc Harvey, RN    514-376-3330 ext 2776    luc.harvey@icm-mhi.org   
Principal Investigator: Anique Ducharme, MD, FRCPC         
Sponsors and Collaborators
Montreal Heart Institute
Canadian Cardiovascular Society
Investigators
Principal Investigator: Robert Avram, MD Université de Montréal
Principal Investigator: Maxime Tremblay-Gravel, MD, MSc Université de Montréal
Principal Investigator: Guillaume Marquis-Gravel, MD, MSc Université de Montréal
Principal Investigator: Olivier Desplantie, MD CM, FRCPC Université de Montréal
Principal Investigator: Anique Ducharme, MD FRCPC Montreal Heart Institute
  More Information

Additional Information:
Responsible Party: Marc Jolicoeur, Lead investigator, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT02590601     History of Changes
Other Study ID Numbers: MP-33-2015-1874 (MP)
First Submitted: October 12, 2015
First Posted: October 29, 2015
Last Update Posted: September 6, 2017
Last Verified: September 2017

Keywords provided by Marc Jolicoeur, Montreal Heart Institute:
PPCM
Bromocriptine
Peripartum cardiomyopathy

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Bromocriptine
Antiparkinson Agents
Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action